Engler Tobias, Fasching Peter A, Lüftner Diana, Hartkopf Andreas D, Müller Volkmar, Kolberg Hans-Christian, Hadji Peyman, Tesch Hans, Häberle Lothar, Ettl Johannes, Wallwiener Markus, Beckmann Matthias W, Hein Alexander, Belleville Erik, Uhrig Sabrina, Wimberger Pauline, Hielscher Carsten, Kurbacher Christian M, Wuerstlein Rachel, Untch Michael, Taran Florin-Andrei, Enzinger Hans-Martin, Krabisch Petra, Welslau Manfred, Maasberg Michael, Hempel Dirk, Lux Michael P, Michel Laura L, Janni Wolfgang, Wallwiener Diethelm, Brucker Sara Y, Fehm Tanja N, Schneeweiss Andreas
Department of Obstetrics and Gynecology, University of Tübingen, Tübingen, Germany.
Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany.
Geburtshilfe Frauenheilkd. 2022 Jul 12;82(10):1055-1067. doi: 10.1055/a-1880-0087. eCollection 2022 Oct.
Comprehensive data from prospective clinical trials have led to a high level of evidence establishing CDK4/6 inhibitors in combination with endocrine treatment (CDK4/6i + ET) as a standard for the treatment of HER2-negative, hormone receptor-positive (HER2- HR+) breast cancer patients in the first-line advanced therapy setting. Data on patient populations that have been treated in the real-world setting may provide an insight into changes of patient characteristics and prognosis over time. The data were extracted from the prospective real-world registry PRAEGNANT (NCT02338167). Patients had to have HER2- HR+ advanced breast cancer in the first-line metastatic setting. The chosen therapies were described as well as progression-free survival (PFS) and overall survival (OS) in relation to the given therapies and time periods during which they were indicated. CDK4/6 inhibitors have been rapidly implemented since their introduction in November 2016. In recent years (2018 - 2022), about 70 - 80% of the patient population have been treated with CDK4/6 inhibitors, while endocrine monotherapy was given to about 10% and chemotherapy to about 15% of all patients. The prognosis was worst in patients treated with chemotherapy. Recently, mainly patients with a good prognosis are being treated with endocrine monotherapy, and patients who are treated with chemotherapy have an unfavorable prognosis. The PFS and OS of patients treated with CDK4/6i + ET have remained similar over time despite changes in patient characteristics. A treatment with CDK4/6i + ET has rapidly become the therapy standard for patients in the first-line advanced breast cancer setting. After the implementation of CDK4/6i + ET, endocrine monotherapy is only given to patients with a very favorable prognosis, while chemotherapy is provided to patients with a rather unfavorable prognosis. These changes in patient characteristics did not seem to influence the prognosis of patients treated with CDK4/6i + ET.
来自前瞻性临床试验的综合数据已产生了高水平证据，确立了细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂联合内分泌治疗（CDK4/6i + ET）作为一线晚期治疗环境中HER2阴性、激素受体阳性（HER2- HR+）乳腺癌患者的治疗标准。关于在现实世界环境中接受治疗的患者群体的数据，可能会让人深入了解患者特征和预后随时间的变化。这些数据摘自前瞻性现实世界登记处PRAEGNANT（NCT02338167）。患者必须在一线转移性环境中患有HER2- HR+晚期乳腺癌。描述了所选治疗方法以及与给定治疗方法及其适用时间段相关的无进展生存期（PFS）和总生存期（OS）。CDK4/6抑制剂自2016年11月推出以来已迅速得到应用。近年来（2018 - 2022年），约70 - 80%的患者群体接受了CDK4/6抑制剂治疗，而约10%的患者接受了内分泌单药治疗，约15%的患者接受了化疗。接受化疗的患者预后最差。最近，主要是预后良好的患者接受内分泌单药治疗，而接受化疗的患者预后不佳。尽管患者特征发生了变化，但接受CDK4/6i + ET治疗的患者的PFS和OS随时间保持相似。CDK4/6i + ET治疗已迅速成为一线晚期乳腺癌患者的治疗标准。在实施CDK4/6i + ET后，仅对预后非常良好的患者给予内分泌单药治疗，而对预后相当不佳的患者给予化疗。患者特征的这些变化似乎并未影响接受CDK4/6i + ET治疗的患者的预后。
